(RTTNews) - Q32 Bio Inc. (QTTB), a clinical-stage biotechnology company announced positive 36-week topline results from Part B of the SIGNAL-AA Phase 2a trial evaluating Bempikibart in patients with severe or very severe alopecia areata (AA).
The SIGNAL-AA study is a randomized, double-blind, placebo-controlled Phase 2a trial conducted in two parts. The Part A was a 12-week proof-of-concept study, while Part B extended treatment to 36 weeks to assess durability of response and long-term safety. Patients were stratified by prior JAK inhibitor exposure, allowing evaluation of efficacy in both treatment-naïve and previously treated populations.
The trial met its primary endpoint, showing a mean percent reduction in SALT score of 35.3% from baseline in the modified intent-to-treat (mITT) analysis. At Week 36, 40% of patients achieved a SALT-20 response in the mITT group, while 30.3% achieved SALT-20 in the intent-to-treat (IIT) analysis of all enrolled patients.
Bempikibart was generally well tolerated, with a safety profile consistent with prior studies and no new safety signals. The therapy also demonstrated favorable pharmacokinetic, pharmacodynamic, and anti-drug antibody characteristics.
"Alopecia areata is a complex, immune-driven disease with limited therapeutic options. The robust efficacy data in a population that includes JAK inhibitor-experienced patients, combined with a differentiated safety profile, demonstrate the potential for bempikibart to be a first-line treatment" said Arash Mostaghimi, of Brigham and Women's Hospital, Harvard Medical School.
Q32 Bio's CEO Jodie Morrison added, "These results highlight the opportunity to deliver a differentiated, targeted treatment option for patients who remain in need of an effective, safe, and more durable alternative to JAK inhibitors."
The company intends to advance Bempikibart into a registration-directed program in the first half of 2027, building on the SIGNAL-AA findings.
QTTB has traded between $1.57 and $15.02 over the past year. The stock closed Friday's trading (July 10, 2026) at $11.21, down 10.96%. In pre-market trading the stock is at $20.20, up 80.20%.
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